About Sollers

Sollers is a graduate school located in New Jersey, specializing in clinical research, drug safety and pharmacovigilance training.

Our graduate certificate and masters programs cover a wide range of subjects tailored to this fast growing industry, and our graduates go on to highly successful careers in the pharmaceuticals industry and healthcare industries.

  • HOURS
  • Monday - Thursday | 10 AM - 7 PM
  • Friday | 12 PM - Midnight
  • Saturday | 12 PM - Midnight
  • Sunday | Closed
  • OPEN 24/7 - sollers.edu
    • PHONE
    • (848) 299-5900
    • Location
    • 100 Menlo Park, Suite 550
      Edison New Jersey 08837 -2488

Location

Call Us Now: 848 299-5900

Sollers Blog

Aggregate Reporting in Drug Safety and Pharmacovigilance

Posted by Doctor Dan on Jun 15, 2017 3:30:33 PM

Over view of the program - Cumulative –or- Aggregate reporting, also known as Periodic Reporting, plays a key role in the safety assessment of drugs. Aggregate reporting involves the compilation of safety data for a drug over a prolonged period of time (months or years), as opposed to single-case reporting which, by definition, involves only individual AE reports. The periodic reports plays an important role in risk-benefit evaluation of the drug and involves collective analysis of cases in the database, monitoring regulatory actions, literature searches etc. They are required to be submitted to various regulatory agencies to comply with the regulatory requirements. The advantage of aggregate reporting is that it provides a broader view of the safety profile of a drug.

Microbilology Lab.jpg

Join the Workshop in Aggregate Reporting in Drug Safety and Pharmacovigilanceand upgrade your skillset today.

 Program Highlights 

  • Industry Relevant Curriculum
  • Access to Oracle Argus Safety database
  • Live Online Sessions 

 Program Curriculum 

  • Introduction to Aggregate Reports
  • Extraction of NDA line listing from Argus Safety for preparation of PADERs
  • Overview of PADERs and its preparation
  • Extraction of ICH line listing from Argus Safety for preparation of PSURs
  • Overview of PSURs and its preparation
  • Literature Search and identification of Potential and Identified Risk
  • Extraction of Case listing for Aggregate reporting purposes

 Methodology 

  • Live Online Sessions via WebEx
  • Hands-on Practical training on the Oracle Argus safety database.

 Duration 

  • 20 hours of Live Online Sessions via WebExand
  • Hands-on training on the Oracle Argus Safety database

 Tuition Fee - $ 999

 Key Takeaways 

At the end of this Program you will be able to learn:

  • The procedure to generate line listings
  • Summarize tabulation of ADR cases in Oracle Argus Safety Database
  • Detailed discussion on
  • Content and preparation of the reports
  • Country specific requirements
  • Guidelines governing periodic reports

 Who should enroll? 

  • Life Science/Medical/Pharmacy/Nursing Graduates
  • Drug Safety associates
  • Drug Safety assistants
  • Pharmacovigilance Associates

 For more information please contact:

Sollers College
Unit 1850, 55 Parsonage Road,
Edison, New Jersey 08837
Phone: 848-480-0090.  
Email id: workshops@sollers.edu
Website: www.sollers.edu 

Topics: Aggregate Reporting in DSP